Beneficial results of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in randomized controlled trials of patients at high, intermediate and low surgical risk have led to substantial changes in North American and European guideline recommendations. To examine influence of these guideline changes on a real world TAVI cohort, we evaluated how risk profiles and clinical presentation of TAVI patients and outcomes of TAVI procedures developed in our single-center patient cohort over a period of 12 years.

 

In-hospital databases were retrospectively screened for patients who underwent TAVI between 03/2008 and 12/2020 at our center. Baseline, procedural and outcome parameters were compared between three time periods of TAVI procedures (period 1: 2008 to 2012, period 2: 2013 to 2017, period 3: 2018 to 2020). Outcome parameters were adjudicated according to VARC-2 definitions. 

Between 03/2008 and 12/2020, a total of 3,678 patients underwent TAVI at our center. Of these, n=722 were assigned to the period 1 group (2008 to 2012), n=1,772 were assigned to the period 2 group (2013 to 2017), and n=1,183 were assigned to the period 3 group (2018 to 2020). There was no significant change regarding age over time (period 1: 80.4±7.0, period 2: 80.2±6.9, period 3: 80.3±7.0; p=0.845). However, rates of peripheral artery disease, status post stroke, chronic lung disease, malignant disease, or prior cardiac surgery significantly decreased over time resulting in significantly reduced EuroSCORE II (period 1: 7.0±5.4, period 2: 6.7±6.3, period 3: 4.4±5.1; p<0.001). Use of transapical access was dramatically reduced over time (period 1: 57.1% (n=412), period 2: 21.1% (n=371), period 3: 2.4% (n=27); p<0.001). Rate of postprocedural acute kidney injury stage II or III (period 1: 7.8% (n=56), period 2: 4.9% (n=87), period 3: 3.3% (n=38); p<0.001) and of permanent pacemaker implantations (period 1: 19.3% (n=139), period 2: 16.1% (n=283), period 3: 9.3% (n=100); p<0.001) continuously declined over time. Furthermore, rate of the VARC-2 combined endpoint device success significantly increased over time (period 1: 87.5% (n=632), period 2: 92.4% (n=1634), period 3: 95.4% (n=1108); p<0.001). There was no improvement over time regarding disabling stroke (period 1: 3.5% (n=25), period 2: 3.8% (n=68), period 3: 3.2% (n=37); p=0.629). Furthermore, 30-day mortality declined over time (period 1: 9.3% (n=67), period 2: 6.3% (n=111), period 3: 4.4% (n=51); p=0.031). 

 

Reflected by frequency of relevant comorbidities and EuroSCORE II, risk profiles changed dramatically towards lower risk in our TAVI cohort over the past 12 years although mean patient age remained largely unchanged. In conclusion, despite profound changes in guideline recommendations for treatment of valvular heart disease, increased age still appears to be the main reason to choose TAVI over SAVR. Significant improvements in early outcomes suggest favorable influence of less invasive access routes, improved device platforms and growing user experience over a period of 12 years. The extension of TAVI treatment to a cohort of lower risk underlines the importance of the interdisciplinary heart team in which an in-depth discussion of every patient with aortic valve disease enables an optimal individualized treatment.